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Alkmini Sheehan

Alkmini Sheehan

Senior GMP Quality Assurance Director Quality Operations Leader 🔹 Quality Systems Owner 🔹 Process Improvement Champion 🔹 Global Pharmaceutical Industry

Greater Philadelphia

Forward-thinking, resourceful, and reliable Senior Quality Assurance Leader offering progressive experience driving Good Manufacturing Practices (GMP) and continuous improvement initiatives in the pharmaceutical industry.

Highly organized and collaborative professional able to lead global cross-functional teams and cultivate strong partnerships with key stakeholders.

Grasp the big picture, focus on details, and manage multiple priorities with efficiency, accuracy, and timeliness.

Excel at analyzing all aspects of complex problems to craft solutions and execute corrective action.

Committed to consistently exceeding expectations utilizing sound judgment, disciplined decision-making, sense of urgency, and personal accountability for results.


APPLIED SKILLS & KNOWLEDGE
☑️ QMS Implementation
☑️ Change Control Management
☑️ Annual Product Review (APR)
☑️ CAPA Management
☑️ Deviation Management
☑️ Stability QA Approver
☑️ Analytical QA Approver
☑️ Biologics/Small Molecule
☑️ Product Complaint Management
☑️ Product Disposition
☑️ Process Improvement
☑️ LMS Implementation
☑️ QA Systems Integration
☑️ IND/IMPD/NDA CMC Review
☑️ Regulatory Compliance


Experience:

  • Senior Analyst, External GMP Quality Operations (Johnson & Johnson)
  • Associate Director, GMP Quality Assurance (Loxo Oncology at Lilly)
  • Senior Analyst, Quality Systems (Merck)
  • Director, GMP Quality Assurance (Loxo Oncology at Lilly)
  • Manager, Global Medical Safety Operations (Johnson & Johnson)
  • Manager, External GMP Quality Operations (Ophthotech)
  • Senior Director, GMP Quality Assurance (Loxo Oncology at Lilly)
  • Manager, Global Process Owner, Quality Systems (received two promotions) (Johnson & Johnson)

Skills:

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